Label: ACHE AND PAIN RELIEF TO GO- aspirin and caffeine powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 8, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (per powder)Purpose
    *
    nonsteroidal anti-inflammatory drug
    Aspirin 650mg (NSAID)*Pain reliever
    Caffeine 60mgPain reliever aid
  • Uses

    Temporarily relieves:

    • muscle pain
    • minor arthritis pain
    • headache
    • pain of colds
  • Warnings

    Reye's syndrome

    Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for longer than directed

    Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    When using this product limit use of caffeine-containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat

    Stop use and ask a doctor if

    • an allergic reaction occurs (seek medical help right away)
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever lasts more than 3 days
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and over:

    • see instructions in red box for opening packet
    • place 1 powder on the tongue and swallow with or without water
    • repeat every 4-6 hours, while symptoms persist
    • do not take more than 4 powders in 24 hours

    children under 12 years: ask a doctor

  • Inactive ingredients

    acesulfame potassium, citric acid, flavor, glucose, sucralose

  • Questions?

    1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx®
    Breakthrough Products, Inc.
    Denver, CO 80202

  • PRINCIPAL DISPLAY PANEL - 1 Powder Packet

    New!

    NO
    WATER
    REQUIRED
    POUR DIRECTLY IN MOUTH

    URGENT Rx®
    FAST
    POWDERS

    ◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶

    ACHE &
    PAIN

    URGENT Rx®
    RELIEF
    TO-GO

    ASPIRIN (NSAID) + CAFFEINE /
    PAIN RELIEVER + ADJUVANT

    lemon-lime

    distributed by UrgentRx
    1 POWDER PACK

    PRINCIPAL DISPLAY PANEL - 1 Powder Packet
  • INGREDIENTS AND APPEARANCE
    ACHE AND PAIN RELIEF TO GO 
    aspirin and caffeine powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin650 mg
    caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E) caffeine60 mg
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    dextrose (UNII: IY9XDZ35W2)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorLEMON (Lemon-Lime) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51596-008-055 in 1 BOX
    1NDC:51596-008-011 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51596-008-1212 in 1 BOX
    2NDC:51596-008-011 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:51596-008-2424 in 1 BOX
    3NDC:51596-008-011 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:51596-008-011 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:51596-008-1010 in 1 BOX
    51 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34310/01/2012
    Labeler - Breakthrough Products Inc. (962008251)